依格斯医疗科技有限公司校园招聘

发布时间：2009-04-11
工作地点：
信息来源：南京医科大学
职位类型：全职
职位描述
依格斯医疗科技有限公司校园招聘 [日期：2009-04-08] 来源： 作者： [字体：大 中 小]

依格斯医疗科技有限公司介绍

--- 致力于国际化的中国临床研究

校园宣讲及招聘时间:4月10日下午2:30

校园宣讲及招聘地点:先知楼302报告厅

专业需求:临床、预防、护理

依格斯（北京）医疗科技有限公司成立于1999年，总部位于北京，是中国较早的临床型CRO公司。作为中国领先的专业合同研究组织（CRO），依格斯在全球设有17家办事机构，拥有300余名优秀的员工，曾为120多家大型跨国制药企业和生物技术公司提供过专业服务。公司业务部门配备完善，主要职能部门包括：法规事务部、临床医学部、数据管理部和统计分析部、质量控制部和商务发展部等。依格斯凭借丰富的操作经验，已经在行业内树立了良好的声誉，曾为120多家大型跨国制药企业和生物技术公司提供过专业服务。长期以来我们与政府相关部门、国内外制药企业或机构以及众多医疗机构（药物临床研究基地）等建立了良好的合作关系。凭借丰富的资源优势、广泛的合作伙伴、深厚的专业功底，依格斯将助您在亚洲医药发展一臂之力。

我们的服务：

·新产品评估、产品开发咨询与战略策划；

·产品注册：药品、医疗器械、生物制品、保健品、化妆品；

·I-IV期临床试验监查和管理；

·临床试验方案设计、受试者招募、GCP培训、医学报告撰写及可行性调研；

·数据管理、统计分析。

我们的办事机构：

·在北京、上海、广州、南京、成都、重庆、沈阳、大连、南京、武汉、西安、杭州、哈尔滨、天津等城市设有办事处；

·在美国的旧金山、德国的科隆设有代表处；

·公司计划从2008年开始在中国台湾、中国香港、韩国、新加坡、马来西亚开展业务，逐渐成长为一家国际性的CRO公司。

我们的经验：

·依格斯的医学部目前有300余名全职员工，在中国40多个城市的150家医院进行了140多项临床试验，涉及20多个治疗领域，入组病例超过50000人（包括化学药品、疫苗、生物制品、医疗器械及体外诊断试剂等，重点治疗领域包括肿瘤、心血管、内分泌及感染性疾病等），多次接受跨国公司稽查（至2007年5月共15次），并且在国际多中心临床试验中也有着丰富的经验（12项）。

·法规事务部有22名员工，目前已经获得过200多项新产品批件，包括60余个进口药，3个I类新药、10个国际多中心临床试验批件，一百余个器械、诊断试剂、保健品、化妆品的批件。

·数据管理团队有30余名员工，配备有Oracle Clinical 和SAS软件，开展了60多项数据管理和统计分析的项目，并已达到美国FDA 21CFR PARTII的标准。数据管理和统计分析是公司今后重点发展及推广的服务之一，目前已与多家跨国药企建立合作伙伴关系。

Job Descriptin for statistician

（统计师职位描述）

Responsibilities

- Assists in study design and development of statistical section in clinical trial protocols

- Assists sample size and statistical power calculations and randomization schedule generation

- Attributes to development of statistical analysis plans including table shells design for individual studies

- Supports data safety monitoring board (DSMB) or data monitoring committee (DMC) and clinical endpoints committee (CEC) regarding to statistics analysis

- Participate in statistical support for CRF design, database development, data validation plan and blinded data review

- Performs SAS programming to generate tables, listings, figures, and statistical analyses

- Assists higher level biostatisticians for the project tasks

- Conducts literature searches to support statistical team

- Performs other duties assigned by supervisor

Qualifications:

- An advanced degree (Ph.D. or M.S.) in biostatistics, statistics or related field

- Experience of statistical analysis in the pharmaceutical industry is preferred

- Ability to deal with sensitive inquiries or complaints from clients or potential clients and to protect confidentiality

- Be knowledgeable in drug agencies (e.g. FDA) regulations and requirements governing the conduct of drug and medical device studies including, but not limited to, GCP and ICH requirements

- Good communication and interpersonal skills

- Proficient working in a PC/Windows environment

- A good command of English language if one’s native language is not English

Job Descriptin for SAS pROGRAMMER

（SAS程序员职位描述）

Responsibilities

- Develops SAS programs to produce data listings and Case Report Form Tabulations (CRT) as by domain or by subject

- Builds standard tabulation datasets according to certain industry standard or the client’s requirements

- Creates derived or analysis datasets according to certain industry standard or the client’s requirements based on the statistical analysis plan

- Develops SAS programs to implement statistical analyses to generate tables, listings and figures as specified in the statistical analysis plans

- Performs validation of and quality assurance aspects of all SAS programming activities

- Develops SAS programs for other needs

- Consults on other statistical programming tasks, such as support for CRF design, database development, data validation plan and blinded data review

- Assists higher level SAS Programmers with the projects or other tasks

- Performs other duties assigned by supervisor

Qualifications:

- Bachelor degree in a scientific or technical area (statistics or related subjects is preferred); An advanced scientific degree is desirable

- Knowledge of programming methodology; familiarity of CDISC data standards is preferred

- Experience with Base SAS (data step programming), SAS/SQL, SAS/MACRO, SAS/ODS, SAS/GRAPH, SAS/ACCESS; experience of clinical database setup is preferred

- Ability to deal with sensitive inquiries or complaints from clients or potential clients and to protect confidentiality

- Knowledgeable in the drug agencies (e.g. FDA) regulations and requirements governing the conduct of drug, biologic and device studies including, but not limited to, GCP and ICH requirements

- Very good communication and interpersonal skills

- Proficient working in a PC/Windows environment

- A good command of English language if one’s native language is not English

Campus Recruiting Proposal

POSITION

CRA Assistant 80 Vacancy

Department: Clinical Operation Department, Excel PharmaStudies. Inc.

Location: Shanghai(60), Nanjing(20).

POSITION SUMMARY

The CRA Assistant is responsible for conducting on-site clinical monitoring, coordinating clinical studies, motivating investigators and ensuring all documentation timely collection etc.; pays a key role in clinical research area; worksclosely with sponser,investigator and other members of the team to deliver the overall objectivies and goals of the clinical operation department.

REQUIREMENTS

Education

- A bachelor degree in Medical or Pharmaceutical related area;

Main Responsilities

Assist CRAs/PMs in the administration, scheduling and coordination of study activities including but not limited to:

- Support CRA/SCRA/PM in conducting project.

- Prepare and distribute study-related documents.

- Maintain and audit study files as specified in SOPs.

- Receive and review site regulatory documents.

- Coordinate assembly of study related materials and investigational product.

- Lead in the establishment and maintenance of effective systems for project documentation, tracking and information retrieval.

- Assist with budgeting and tracking study invoices and finances.

- Plan, schedule and minute meetings and teleconference to support clinical trials, sites and the clinical teams.

- Implement project support processes and organization at the direction of the CRA/PMs.

- Coordinate information and communication for designated studies.

Key Competencies

- Ability to work independently, organize and prioritize with minimal supervision.

- Familiarity with medical terminology.

- Knowledge of SFDA regulations and GCP/ICH Guidelines a plus.

- Competence with MS Office programs.

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